Hydrocodone Combination Products Rescheduling
The U.S. Drug Enforcement Administration will allow continued refills of hydrocodone combination products (HCP) prescriptions written before October 6 under the rules governing refills of Schedule III-V prescriptions. Those rules are as follows:
- All prescriptions for HCPs must comply with 21 U.S.C. 829(a) and must be issued in accordance with 21 CFR part 1306 and subpart C of 21 CFR part 1311 as of October 6.
- No prescription for HCPs issued on or after October 6, 2014, shall authorize any refills. Any prescriptions for HCPs issued before that date, and authorized for refilling, may be dispensed in accordance with 21 CFR 1306.22–1306.23, 1306.25, and 1306.27, if dispensed before April 8, 2015.
The DEA prefers that pharmacists maintain the original prescription number on all refills of HCPs prescriptions written before October 6. However, DEA will allow new prescription numbers to be assigned to each refill under this provision:
- A clear audit trail must link each successive refill back to the original prescription in a way that ensures the HCP prescription is refilled no more than five times in six months from the date it's issued, and as noted on the original prescription.